(29 days)
The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
The provided text describes a 510(k) summary for a Cordless Coil for MRI systems, focusing on its substantial equivalence to predicate devices rather than directly presenting explicit acceptance criteria and a detailed study proving performance against those criteria.
However, based on the information provided, we can infer the approach taken by the manufacturer to demonstrate safety and effectiveness for substantial equivalence.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Cordless Coil. Instead, it asserts substantial equivalence to predicate devices. This implies that the performance of the Cordless Coil is expected to be as good as or similar to the predicate devices, without introducing new safety risks.
- Acceptance Criteria (Inferred): Performance (image quality, signal-to-noise ratio, spatial distribution of protons, T1/T2 characteristics that allow for diagnosis) to be similar to legally marketed predicate devices without introducing new safety risks.
- Reported Device Performance: The document states, "The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices." This is a qualitative assertion of equivalence rather than a quantitative performance report.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any details about a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the Cordless Coil's performance directly. The basis of substantial equivalence is comparison to predicate devices, rather than a de novo clinical study with a distinct test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no distinct test set with ground truth is described, there's no information about the number or qualifications of experts used to establish ground truth. The intended use statement mentions "When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses," implying that trained physicians are the ultimate interpreters of the images, but this is not about establishing ground truth for a study.
4. Adjudication Method:
Given the lack of a described test set and ground truth establishment, there is no information on any adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding human reader improvement with or without AI assistance. This device is a hardware component (MRI coil), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
There is no mention of a standalone algorithm performance study. This is a hardware device, not an algorithm.
7. Type of Ground Truth Used:
Since no specific performance study with a test set is described, there is no information regarding the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set:
This device is a hardware component (MRI coil), not an AI/machine learning algorithm that requires a training set. Therefore, there is no information on a training set sample size.
9. How the Ground Truth for the Training Set Was Established:
As above, there is no information on how ground truth for a training set was established, as this is not an AI/ML device.
Summary of the Study (as described for substantial equivalence):
The "study" presented here is a substantial equivalence argument based on technical characteristics and intended use comparison to legally marketed predicate devices.
- Name of Study: Not explicitly named as a formal "study," but rather a 510(k) "Premarket Notification" demonstrating substantial equivalence.
- Objective: To demonstrate that the Cordless Coil for MAGNETOM Concerto and C! MR Systems is as safe and effective as existing predicate devices.
- Methodology (Inferred from 510(k) process): Comparison of the new device's design, materials, performance specifications (which are not detailed in this summary), and intended use against those of the predicate devices. The rationale is that if the new device has "the same intended use and similar technical characteristics" and "does not introduce any new safety risks," then it is substantially equivalent.
- Predicate Devices Used:
- Evidence for Equivalence: Conformance to FDA recognized NEMA Standards for performance and safety parameters, and IEC standard IEC 60601-2-33: 2002 for safety issues with Magnetic Resonance Imaging Devices.
- Conclusion: The manufacturer's opinion is that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices. The FDA concurred with this determination, as indicated by the clearance letter.
Essentially, for this type of medical device 510(k) submission, the "study" is the comprehensive documentation and comparison to predicate devices, rather than a clinical trial with specific performance metrics against an established ground truth. The "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to previously cleared devices and adheres to relevant safety standards.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.